FDA 510(k) Application Details - K081964

Device Classification Name Wheelchair, Powered

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510(K) Number K081964
Device Name Wheelchair, Powered
Applicant PERMOBIL AB
BOX 120
TIMRA S-861 23 SE
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Contact JAN ASTROM
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 07/10/2008
Decision Date 07/29/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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